Clinical Study to Evaluate the Efficacy of VR506 Using a New Inhaler for the Treatment of Asthma

Exclusion Criteria

• •Regular use (≥3 times per week) of topical steroids taken to treat dermatitis, rhinitis or allergic conjunctivitis, within 28 days of the Screening Visit
• •Subjects who have or who have had an upper or lower respiratory tract infection within 28 days of the Screening Visit
• •Subjects with asthma that required admission to an intensive care unit and/or ventilation within the previous 12 months
• •History of lung cancer
• •Subjects with "brittle asthma", defined as patients with asthma who either maintain over many months a wide variation (\>40%) in peak expiratory flow (PEF) between morning and evening measurements despite moderate to high doses of ICS, or are prone to acute, severe and often unpredictable attacks of asthma that may be fatal, on a background of apparently good asthma control
• •History or current diagnosis of human immunodeficiency virus (HIV) infection
• •Active chronic hepatitis B or C infection. If the patient's screening test is positive for hepatitis B surface antigen, the patient should be excluded unless the investigator, after a careful review of the patient's medical history and current laboratory tests of liver function, can exclude the possibility of recent or current infection
• •Persistent arterial hypotension, with average systolic blood pressure (SBP) readings of ≤95 mmHg
• •Subjects who have any clinically significant abnormality or finding from examination, tests, or history that may compromise subject safety, specifically any history of cardiac, renal or hepatic impairment
• •Subjects with an abnormal ECG
• •Persistent elevation of blood pressure, with average SBP readings of ≥160 mmHg or average diastolic blood pressure (DBP) readings of ≥100 mmHg
• •Pregnant or lactating females
• •Participation in another clinical study in the 28 days prior to the Screening Visit
• •Current or a history of drug or alcohol abuse or dependence according to World Health Organization criteria in the 12 months prior to the Screening Visit or evidence of such abuse as indicated by laboratory assays conducted during the screening evaluation
• •Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia, or predisposition to low levels of serum potassium
• •Inability to communicate well with the investigator
• •Evidence of clinically significant renal, hepatic, cardiac, pulmonary (apart from asthma) or metabolic dysfunction, e.g. diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia, or predisposition to low levels of serum potassium
• •Donation of ≥450 mL of blood or blood products within the previous 12 weeks prior to the Screening Visit
• •History of allergy, intolerance or contraindications to corticosteroids, lactose, or severe allergy to milk proteins
• •Consumption of alcohol- or caffeine-containing foods or beverages from midnight before or during the Screening Visit. The visit can be rescheduled once before the subject is excluded
• •History of medically diagnosed chronic respiratory diseases (other than asthma) e.g. chronic obstructive pulmonary disease
• •Subjects with previously clinically or radiologically diagnosed osteoporosis and/or those receiving regular treatment (more than 1 month duration) with oral or parenteral corticosteroids in the last year prior to the Screening Visit